Robot-Assisted Hand Motor Therapy for Subjects With Hemiparetic Stroke

Phase 2

Completed

• Conditions: Stroke
• Interventions: Device: Hand & Wrist Assisting Robotic Device

• Registration Number: NCT01244243
• Lead Sponsor: University of California, Irvine

Brief Summary

The purpose of this study is to develop and assess the effectiveness of robot-assisted movement therapy in enhancing hand motor function in subjects with chronic hemiparetic stroke, and to identify predictors of treatment response.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2010-11-03
• Study First Submitted QC: 2010-11-17
• Study First Posted: 2010-11-19
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Results First Submitted: 2014-12-12
• Results First Submitted QC: 2015-05-22
• Results First Posted: 2015-05-27
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-16
• Last Update Posted: 2016-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

1. At least 18 years old
2. Had stroke between 11-26 weeks ago
3. Have some weakness in one of your wrists or hands due to stroke
4. Did not have too much disability prior to stroke
5. Do not have major depression

Exclusion Criteria

1. Non-English speaking
2. If you have trouble keeping good attention
3. Pregnant, advanced liver, kidney, heart, or lung disease
4. Terminal medical diagnosis or major neurological or psychiatric disease apart from stroke
5. Cannot undergo MRI scanning
6. Have history of brain surgery or seizures

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Active therapy	Hand & Wrist Assisting Robotic Device	All subjects receive the same active robotic therapy, there is no placebo arm, as a key goal of this study is to define predictors of response to active treatment.

Primary Outcome Measures

Name	Time	Method
Action Research Arm Test	change from baseline to 1 month post-end treatment, Intention To Treat	The Action Research Arm Test is a 19 item measure divided into 4 sub-tests (grasp, grip, pinch, and gross arm movement). Performance on each item is rated on a 4-point ordinal scale ranging from: 3: Performs test normally 2: Completes test, but takes abnormally long or has great difficulty 1: Performs test partially 0: Can perform no part of test. The test is used to determine upper limb function, 0-57 points with higher is better, 57 is the highest score indicating normal arm movement.
Arm Motor Fugl-Meyer Test	change from baseline to 1 month post-end treatment, Intention To Treat	The Arm Motor Fugl-Meyer test is an assessment of Sensorimotor Recovery After Stroke. It is a 33 item measure with 3 subgroups which are Proximal, Wrist/Hand, and Coordination/Speed. The scaling for each item works on a scale of 0-2 with 0 being not able to be done, 1 being partially done, and 2 being done normally. The scoring goes from 0-66, higher is better, 66 is considered a normal score with no noticable complications in movement.

Trial Locations

Locations (1)

University of California, Irvine; 🇺🇸 Irvine, California, United States